LyoFlow: Real Time Vapour Mass Flow measurement. The new PAT tool to complete & monitor lyophilisation process under QbD approach
EducationalEmbracing innovation: towards a new paradigm for Freeze-drying
2025-06-05 | 02:15 PM - 02:30 PM | TPD Room
Information
The pharmaceutical industry is increasingly embracing Quality by Design (QbD) principles to enhance process understanding and ensure robust product development. Lyophilization, a critical step in the production of biologics and injectable formulations, presents significant challenges in achieving optimal cycle design while maintaining product quality and efficiency.
LyoFlow is an innovative technology that facilitates the application of QbD in lyophilization process development, providing real-time insights into key parameters such as mass flow, sublimation dynamics, and heat transfer. By leveraging advanced analytics, LyoFlow enables pharmaceutical manufacturers to optimize cycle conditions, reduce development time, and enhance batch-to-batch consistency.
This presentation will explore how LyoFlow integrates into the lyophilization workflow, showcasing its impact on process control. Several case studies will be shared, demonstrating successful implementations where LyoFlow has led to improved process efficiency, reduced variability, and enhanced product stability.
By adopting LyoFlow, pharmaceutical companies can achieve a science-based, data-driven approach to lyophilization, ensuring robust and scalable manufacturing processes that align with regulatory expectations.